NCT05881902

Brief Summary

Disability is part of being human. He estimates that the prevalence of disability among women is 60% higher than that of men. Disabled women coexist in a dual state of vulnerability where "being a woman" and "being a disabled person" have two social disadvantages. Among people with disabilities, women with disabilities (WWD) have higher unmet healthcare needs than women without disabilities. Cancer is an important public health problem and cause of death all over the world. Among the most common cancers in women; breast, uterine corpus, ovarian and cervix cancers are seen to be prominent, respectively. It is known that with regular examinations and screenings, early diagnosis of breast and cervical cancer increases the chance of treatment. International studies show that women face barriers and difficulties in accessing reproductive health and cancer screening services. In studies, it was stated that especially women with disabilities living in rural areas had lower mammography and Pap-smear tests compared to women without disabilities. In recent years, the Health Belief Model has been used frequently to examine the effect of health beliefs on cancer screening behaviors in women and to increase screening rates. The model explains the beliefs and attitudes that affect individuals' behaviors. According to the model; If a person has a desire to prevent illness or a belief in recovery, he recommends taking a specific health action to prevent illness as a positive behavior. It was emphasized that nurses have important roles and responsibilities in the protection and development of health, and that they can identify individuals with disabilities who are considered "fragile", and provide health education and counseling to these groups. It is thought that the "disabled-friendly accessible health care" practices under the guidance of the Health Belief Model will bring the preventive health care behavior of women with disabilities to the desired level. Disabled women experience inequalities in benefiting from routine health services and health screening services in special areas such as reproductive health and protection from women's cancers. Being diagnosed with cancer is undoubtedly devastating for anyone. For this reason, it becomes more important to raise awareness about the prevention, prevention, early diagnosis and development of a healthy lifestyle in women with physical disabilities, and to encourage health-seeking behaviors.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

February 27, 2023

Last Update Submit

May 20, 2023

Conditions

Keywords

cancer screeningcancer early detectionphysically disabledearly screeninghealth blief modelbreast cancercervix cancerawareness

Outcome Measures

Primary Outcomes (1)

  • The Gynecological Cancers Awareness Scale

    The Gynecological Cancers Awareness Scale consists of 41 questions in total, with a minimum of 41 and a maximum of 205 points that can be obtained from the scale. The increase in the scores obtained from the scale indicates that the awareness of gynecological cancer increases.

    12 weeks

Secondary Outcomes (1)

  • Champion's Health Belief Model Scale for Breast Cancer and Screening

    12 weeks

Other Outcomes (2)

  • Cervical Cancer and Pap-Smear Test Health Belief Model Scale

    12 weeks

  • Evaluation Form for Participation in Screening of Common Cancers in Women

    12 weeks

Study Arms (2)

İntervention 1: Cancer awareness training based on the Health Belief Model

EXPERIMENTAL

Awareness training based on the Health Belief Model will be given to the participants in the Intervention 1 group during home visits in order to eliminate the lack of information about the common female cancers in women and to increase their awareness. For 3 months, intervention 1 group will be given applications to reinforce their awareness in the education based on the Health Belief Model (for BSE and KKVM, erasable calendar magnets, booklets, phone cases and accessories themed as "common cancers awareness in women" as a reminder, phone call) will be made.

Behavioral: HEALTH FAITH MODEL GUIDED IN CANCER FREQUENTLY SEEN IN WOMEN EARLY DIAGNOSIS AND SCREENING METHODS EDUCATION

İntervention 2: Standart cancer education

EXPERIMENTAL

Participants in the Intervention 2 group will be provided with the standard training applied at KETEM by the Ministry of Health on female cancers, which are frequently seen in physical women, during home visits. The training will be held in the form of power-point presentation, question and answer. For 3 months, intervention 2 groups will be applied to reinforce their awareness in standard education (sms reminder).

Behavioral: STANDART CANCER EDUCATİON

Interventions

A total of 4 home visits and 2 phone calls will be made by giving awareness training based on the Health Belief Model to the participants in the Intervention 1 group in order to eliminate the lack of information about the common female cancers in women and to increase their awareness. For 3 months, intervention 1 group will be given applications to reinforce their awareness in the education based on the Health Belief Model (for BSE and KKVM, erasable calendar magnets, booklets, phone cases and accessories themed as "common cancers awareness in women" as a reminder, phone call) will be made

İntervention 1: Cancer awareness training based on the Health Belief Model

The participants in the intervention 2 group will be given the standard training applied by the Ministry of Health in KETEM for women's cancers during home visits, and a total of 4 home visits and 2 SMS reminders will be made.

İntervention 2: Standart cancer education

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOur sample is considered based on biological sex.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being physically disabled
  • Having a disability to perform KKMM and KKVM
  • Being between the ages of 18-65 (since these are the age ranges at which screening is started),
  • Being married or living with a spouse (for participation in cervical cancer screening),
  • Not to do KKMM and KKVM regularly every month,
  • Never or in the last three years have not had a pap smear test, CMM or mammography,
  • Not being pregnant, breastfeeding or postpartum,
  • Not having a history of common cancers in women,
  • Accepting to participate in the research,
  • Being literate, accessible and communicative,
  • Absence of severe psychiatric problems

You may not qualify if:

  • Hearing impairment
  • Being visually impaired
  • Being mentally handicapped
  • A physically disabled woman who gives up working at any stage of the study will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yildirim Beyazit University

Ankara, 06760, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

NeoplasmsBreast NeoplasmsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

YEŞİM KAYAPA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The collected data will be analyzed by an independent statistician. The fact that the intervention 1 and intervention 2 groups of the study are known by the researcher and the women with physical disabilities do not know, makes it a double-blind randomized controlled study.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Randomized controlled experimental design
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

February 27, 2023

First Posted

May 31, 2023

Study Start

January 1, 2023

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

It can be used in metaanalysis research, but provided that you receive an information mail.

Locations